Efficacy And Safety Of Adalimumab In Patients With Crohn’s Disease

Objective:Crohn’s disease(CD)is a recurrent and incurable chronic intestinal disease.Due to the limited efficacy and large side effects of traditional medical treatment drugs,biological agents have gradually become the first-line drugs.This study preliminarily observed the efficacy and safety of Adalimumab(ADA)in the treatment of patients with CD,providing an experience for the clinical use of ADA.Methods:This study was a single-center retrospective study of patients with CD treated with ADA in Zhongda Hospital affiliated of Southeast University from January 2020 to January 2022.ADA was subcutaneously injected once every 2 weeks,160 mg for the first time,80 mg for the second time,and 40 mg for each time thereafter.General clinical data of the patients were collected,including gender,age,smoking history,disease course,lesion site,and previous medication status.Meanwhile,relevant laboratory tests,such as hypersensitive C-reactive protein,erythrocyte sedimentation rate,fecal calprotectin,etc.,were collected.The results of digestive endoscopy and imaging were collected.The baseline and the incidence of adverse events at 12,24,48,and 72 weeks of medication were evaluated according to the clinical manifestations of the patients.Statistical analysis SPSS 25.0 and GraphPad Prism 9 software were used for statistical analysis of various indicators such as remission rate,response rate,mucosal healing rate,and incidence of adverse reactions.Results:(1)A total of 50 patients with CD were included in this study,including 2 patients in remission stage(1 patient had delayed hypersensitivity to infliximab,1 patient was complicated with spinal arthritis),9 patients in mild activity stage,34 patients in moderate activity stage,and 5 patients in severe activity stage.48 of all patients had received 5-aminosalicylic acid;Corticosteroids were used in 42 patients;39 patients had used immunosuppressant;7 patients had previously used infliximab(1 patient had delayed allergy to infliximab,6 patients had a secondary loss of response to infliximab),and 43 patients never used biological agents.(2)The clinical remission rates were 44.0%(22/50),61.0%(25/41),63.6%(21/33)and 46.7%(7/15)at 12,24,48 and 72 weeks after ADA administration,respectively.The clinical response rates were 74.0%(37/50),70.7%(29/41),63.6%(21/33)and 46.7%(7/15),respectively.The endoscopic remission rates at 12,24,48 and 72 weeks were 37.5%(6/16),33.3%(3/9),16.7%(1/6)and 25.0%(2/8),respectively.The mucosal healing rates were 12.5%(2/16),11.1%(1/9),16.7%(1/6),25.0%(2/8),respectively.The primary nonresponse rate was 18.0%(9/50),and the secondary loss of response rate was 24.0%(12/50).(3)The incidence of adverse reactions was 14.0%(7/50),among which 2 patients showed tuberculosis infection T cell test changed from negative to positive after 20 weeks and 24 weeks of treatment,and ADA was discontinued for further anti-tuberculosis treatment.One patient developed multiple thyroid nodules 24 weeks after medication and underwent radiofrequency ablation followed by the replacement of biological agents.In addition,2 patients developed alopecia and 2 patients developed the rash.Conclusion:(1)ADA can effectively relieve the clinical symptoms and intestinal disease activities of CD,and is worthy of widespread use.(2)For male patients with no anal fistula,no history of infliximab,low baseline HBI score,and long medication duration,may have better results;for patients with lesion site L3,the efficacy may be worse than L1.In addition,the effect of the original drug and the domestic drug is similar,with no significant difference.(3)ADA has low incidence of adverse effects and no serious adverse events,which can be used as a first-line treatment for CD.